MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS CELSITE; ACCESS PORT SYSTEM

Model Number 4433742

Device Problem Fracture (1260)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/31/2022

Event Type  Injury  

Manufacturer Narrative

Note: product reference 4433742 is not cleared for sales in the usa, but it is similar to the product reference cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr (b)(4).Which complies with our specifications and does not present any discrepancy.No other similar complaint was reported to us on this batch of access ports released in may 2021.Investigation results: we did not receive the complaint sample or the x-ray pictures for investigation.Conclusion: without the complaint sample or the x-ray pictures for investigation, no thorough investigation is possible and we cannot conclude on the real cause of the incident encountered by the customer.If new element become available in the future, we will reopen this complaint.This is a rare incident (0.06%), known risk of the access port implantation.No corrective action is envisaged for the moment.

Event Description

The patient was indwelled at the infusion port 3 years ago and did not return to the hospital for extraction after chemotherapy.Have been active in school.The catheter at the infusion port is broken cleft, thrombosis, risk of pulmonary embolism.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• Manufacturer (Section G): B.BRAUN MEDICAL SAS FRANCE; 30 avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil du poitou, 86360 ; FR 86360
• MDR Report Key: 15392426
• MDR Text Key: 299589134
• Report Number: 9612452-2022-00042
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4433742
• Device Lot Number: 36978319
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Sex: Male